BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM

    MDR report key: 2052964 · Received April 13, 2011

    Report

    Report Number
    3005099803-2011-01261
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDX
    PMA / PMN Number
    K930348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THE BRUSH PRESENT AND EXTENDED, AND THE HANDLE CANNULA WAS BENT AT THE DISTAL END OF THE THUMB RING. THE BRUSH WOULD EXTEND AND RETRACT WITHOUT ISSUE WHEN THE HANDLE WAS ACTUATED. THE DEVICE WAS INSERTED INTO A DUODENOSCOPE WITH A 2.8MM WORKING CHANNEL AND FUNCTIONED PROPERLY WHILE THE SCOPE WAS STRAIGHT AND FULLY DEFLECTED, AND THE BRUSH RETRACTED INTO THE SHEATH ACCORDING TO SPECIFICATIONS. THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE BRUSH WOULD NOT RETRACT INTO THE SHEATH; THE COMPLAINT WAS NOT CONFIRMED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED DURING A CYTODIAGNOSIS PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN CHECKED THE FUNCTIONALITY OF THE DEVICE BEFORE USE, IT WAS NOTED THAT THE BRUSH WOULD NOT RETRACT INTO THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED DURING A CYTODIAGNOSIS PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN CHECKED THE FUNCTIONALITY OF THE DEVICE BEFORE USE, IT WAS NOTED THAT THE BRUSH WOULD NOT RETRACT INTO THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM ENDOSCOPIC CYTOLOGY BRUSH FDX BOSTON SCIENTIFIC - SPENCER M00545000 13996240

    Patients

    Seq Age Sex Outcome Treatment
    1